Arthrex® AR-3351-5500Recalls & reported problems
Arthrex, Inc. · 4K LAPAROSCOPE, 0°, 5.5MM x 300MM · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867029774), received between Aug 18, 2020 and Sep 2, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Burn, Thermal1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON 08/07/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-3351-5500 SCOPE HAD A DETACHED LENS. THIS WAS INVOLVED IN A CASE WHERE THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22937889 ↗MalfunctionJul 19, 2023Scratched Material; Scratched Material
ON (B)(6)2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3351-5500 SCOPE WAS CLOUDY. THIS WAS DISCOVERED DURING AN ARTHROSCOPIC PROCEDURE. THE CASE WAS COMPLETED BY USING A NEW SCOPE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17352604 ↗MalfunctionAug 18, 2020Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A DIAGNOSTIC LAPAROSCOPY PROCEDURE, THE PATIENT GOT BURNED. THE BURN WAS DISCOVERED BY THE PATIENT AFTER THE SURGERY. THE FOLLOWING DEVICES WERE USED DURING THE PROCEDURE: SS9-GYW50W108 / BATCH WO155094, AR-3210-0030, S/N (B)(4), AR-3210-0006, S/N (B)(4), AR-3351-5500, S/N (B)(4). NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.
Patient problems: Burn, Thermal
MAUDE report 10422432 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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